BILL ANALYSIS
SENATE HEALTH AND HUMAN SERVICES
COMMITTEE ANALYSIS
Senator Deborah V. Ortiz, Chair
BILL NO: AB 2297
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AUTHOR: Vargas
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AMENDED: May 20, 2004
HEARING DATE: June 23, 2004
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FISCAL: Appropriations
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CONSULTANT:
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Machi/Margolis/sl
SUBJECT
Imported candy: lead contamination
SUMMARY
Expands the Childhood Lead Poisoning Prevention Act of 1991
(Act) to require the Department of Health Services (DHS) to
regulate the lead content of imported candy.
ABSTRACT
Existing law:
1.Lists lead on California's Proposition 65 list which
includes all toxins that are known to the state to cause
reproductive harm.
2.Prohibits under the Federal Sherman Food, Drug, and
Cosmetic Law, the sale of adulterated food, as defined.
3.Requires DHS to establish a childhood lead poisoning
prevention program to identify and conduct medical
follow-up of high-risk children and to establish
procedures for environmental abatement.
4.Requires DHS to assess a fee against persons who
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contributed to sources of lead contamination to fund the
activities of the state's childhood lead poisoning
prevention program.
This bill:
1.Requires the state to test imported candy to determine
its lead content. Establishes a lead content standard of
zero, or lowest detection limit for imported candy.
2.Requires DHS to have jurisdiction over the regulation of
ensuring imported candy is lead free and gives priority
for testing imported candy received by community-based
organizations.
3.Authorizes DHS to make available funds deposited into the
Childhood Lead Poisoning Prevention Fund for purposes
described in this bill.
4.Authorizes DHS to enter into contracts with county health
officers and county environmental officers to collect
samples of candy for testing.
5.Requires DHS to establish an interagency collaborative
and defines the composition of the collaborative.
6.States that "candy," for the purposes of this bill,
includes only candy imported from a foreign country and
its packaging or wrapper.
7.Authorizes DHS to issue health related advisories, order
the removal of, and to embargo candy found to contain
lead.
FISCAL IMPACT
According to Assembly Appropriations Committee, this bill
would have special fund costs of approximately $862,000 in
2004-05 and on-going annual cost of approximately $1.3
million. (Childhood Lead Poisoning Prevention Fund.)
(The Governor's 2004-05 budget appropriates $25.3 million
from the Childhood Lead Poisoning Prevention Fund. In
2004-05, the fund balance is $2.6 million, down from $7.6
million in 2003-04. This bill increases pressure to either
increase the existing fees or to seek General Fund
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support.)
BACKGROUND AND DISCUSSION
Purpose of the bill
According to the author, a sample testing of candy
(produced in Mexico and sold in Southern California) was
conducted by DHS. These tests revealed that some of the
candy included in the sampling contained much more than the
U.S. Food and Drug Administration (FDA) maximum suggested
amount of lead deemed safe for consumption by a child in
one day. In spite of this discovery, there was no public
health alert issued. In March of 2004, DHS issued its
first state health alert since 2001 when a popular imported
candy, Chaca Chaca, tested well above the FDA
recommendations for any exposure of lead from all food
sources consumed on a daily basis.
Current law does not require DHS, including the Childhood
Lead Poisoning Prevention Program, to test candy that may
be contaminated with lead. The Food and Drug Branch is
authorized to test these candies, but only if the branch
collected the candy samples to be tested. Current law does
not mandate the development of a community/interagency
collaborative to help collect and identify candy that may
be contaminated with lead. Current law also does not
mandate that DHS issue public health advisories once a
candy has been tested and proven through testing to be
contaminated with lead.
Lead poisoning
Lead is a heavy metal that is toxic to the brain and
nervous system. The body mistakes lead for calcium. Lead
that is ingested is absorbed into the blood from the small
intestines. Fifteen percent of ingested lead is absorbed
in the soft tissue, while 85 percent is absorbed in the
bones. Lead in soft tissues can be flushed out by the body
within a month, but the lead that is absorbed into the
bones can take years to be removed from the body.
Lead is extremely toxic, especially to infants, children
and pregnant women. In very small amounts lead can cause
damage to the liver, kidneys, lungs, brain, spleen,
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muscles, heart and central nervous system. It stunts
growth and impairs behavioral development and intelligence
in children. Significant exposure can lead to death.
Damage caused by lead can be irreversible.
In the United States, lead was banned from house paint in
1978 and from gasoline in 1986. As a result of preventive
and removal actions taken, the percentage of U.S. children
with elevated blood-lead levels have dropped dramatically,
from 88 percent in the 1970s to 2 percent in 2000. FDA has
set the acceptable level of lead in candy as 0.5 parts per
million. However, the FDA is currently reviewing that
level and is considering lowering it. In 1991, the federal
Centers for Disease Control and Prevention (CDC) set the
level of concern for lead in children at 10 micrograms of
lead per deciliter of blood. More recent data suggests
that this may be too high; recent studies report effects in
children at lead levels as low as 3 micrograms per
deciliter and possibly lower.
Orange County Register Articles
Over the last two years the Orange County Register
(Register) has conducted an investigation of lead in candy
being sold in Orange County. The Register reports that 90
percent of lead-poisoning cases in Orange County are Latino
children and 75 percent cases statewide are Latino
children. The Register conducted tests on candy being sold
in California and found that many Mexican candies tested
positive for high levels of lead. According to the
Register, 112 brands of candy, most coming from Mexico,
registered dangerous levels of lead over the past decade.
(In evaluating the candy the Register set a level of 0.2
parts per million (ppm) as high. However, the FDA
currently allows lead levels up to 0.5 parts per million.)
The Register looked at various ingredients and processes in
the manufacture of candy coming from Mexico and found that
one source of lead was the chilies used in many Mexican
candies. The soil, because Mexico did not discontinue the
use of leaded gasoline until the mid-1990s, contains lead.
The chilies take on the lead from the ground in which they
are grown. When ground into chili pepper the lead is
ground in with the chilies. However, the lead can be
virtually removed from the chilies if they are washed prior
to being ground into powder. According to the Register,
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some Mexican candy manufacturers use two different
processes in making their candy: one for the Mexican
market and one for the U.S. market; washing chilies only
for candy being exported to the U.S. However, some of the
candy made with unwashed chilies gets imported into the
U.S. illegally.
Similarly, a popular Mexican candy made with tamarind fruit
is made in pots that are glazed with a material containing
lead. The lead leaches from the pot into the candy.
Candy containing levels higher than 0.5 ppm is prohibited
from sale in the United States. However, candy testing
positive for high levels of lead is still coming into
California, most likely from illegal importation practices,
not through normal distribution processes. The Register
asserts that the U.S. and California governments have known
for years of this problem but fail to act.
In April, 2004, FDA put out a statement saying, "The Food
and Drug Administration (FDA) is aware of a problem
associated with lead contamination of some Mexican candy
products being sold in the United States and is advising
parents, care providers and other responsible individuals
that it would be prudent to not allow children to eat these
products at this time? The FDA is taking action to reduce
the risk of potential exposure of children to lead from
these candy products. FDA believes that contamination of
chili powder may be occurring at certain steps in the
manufacturing process. FDA will be working with Mexican
government and industry personnel to resolve this problem."
Senate hearing on lead in imported candy
On June 3, 2004, the Senate Health and Human Services
Committee and the Senate Committee of Governmental
Oversight jointly conducted a hearing on the dangers
associated with lead in candy. Dr. Richard Jackson, State
Public Health Officer within DHS testified that in 2003 of
the 450,000 children tested in California for elevated lead
level, 720 tested positive, which illustrates a significant
decrease over the last decade. Dr. Jackson also stated in
the hearing, that paint and dust still present the highest
risk for lead poisoning in children.
Several issues were raised that are relevant to this
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legislation:
1.The articles published in the Orange County Register
assert that the Childhood Lead Poisoning Prevention
Branch of DHS has adopted a level of 0.2 ppm as the level
of concern for lead poisoning. While that number is
being currently reviewed in studies and evaluated by the
FDA, the Childhood Lead Poisoning Prevention Branch uses
the FDA level of concern number of 0.5 ppm.
2.The Childhood Lead Poisoning Prevention Branch currently
collects fees to administer their programs. There is
question as to whether or not the fees currently
collected from the petroleum and paint industries could
be used to fund the activities required under this bill,
given the nature of the Sinclair Paint decision.
3.In response to an increase in this year's fees, several
companies have not paid the required fees for this past
year and are petitioning the Board of Equalization for an
appeal on the fees. The Committee is awaiting a response
from the Board of Equalization concerning the status of
the fees paid to date and the appeals currently pending.
4.The Orange County Health Officer, Dr. Mark Horton,
testified that the local health departments use health
advisories to attempt to provide education and assistance
in their communities. Dr. Horton stated that health
advisories are helpful to county health departments and
that the most recent advisory led to the removal of one
type of candy from store shelves.
5. Recognizing that there may be food sold in California
that exceeds the allowed levels of lead, committee
members queried DHS staff about food recall procedures.
DHS does not have recall authority in such cases and the
FDA has limited authority. According to the FDA
website, The Federal Food, Drug, and Cosmetic Act, does
not generally authorize FDA to "order" a manufacturer to
recall a food, cosmetic or supplement. The agency may
request a product recall if the firm is not willing to
remove dangerous products from the market without FDA's
written request. Only when a medical device, human
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tissue products, and infant formula pose a risk to human
health, does the law specifically authorizes FDA to
prescribe a recall and to rule on the scope and extent of
the recall.
Previous legislation
AB 256 (Vargas, 2003), would have required DHS to maintain
a program to monitor lead levels in all candy imported from
outside the United States and distributed or sold in the
state. The provisions dealing with lead levels in imported
candy were amended out of the bill prior to the bill being
sent to the governor for signature.
AB 455 (Chu, Chapter 679, Statutes of 2003) enacted the
Toxics in Packaging Prevention Act, which, beginning
January 1, 2006, prohibits the sale of any package, or
product in a package, that includes regulated lead,
mercury, cadmium, or hexavalent chromium, if such metals
have been intentionally introduced during manufacturing or
distribution.
Arguments in support
According to the Environmental Health Coalition (EHC), the
bill's sponsor, "Childhood lead exposure from candies is a
preventable problem and AB 2297 will provide clear
authority to the Department of Health Services to test, ban
and remove lead contaminated imported candies."
Over the years, EHC states that it has investigated many
potential and known sources of lead exposure. Concerned
about the potential for lead contamination in candy, in
2001, EHC's community promotoras collected candies from a
variety of local stores in San Diego and sent them to DHS
for testing. EHC states that in July 2002, DHS released
test results showing two Mexican candies contained
excessive levels of lead. Chaca Chaca was found in three
tests to contain three times the allowable lead levels and
another candy, Tablarindo, was found to contain more than
five times the allowable level of lead. These candies were
not removed from store shelves.
Supporters state, "The candies present an unacceptable
health risk to children, and should have been removed from
store shelves immediately. But almost a year after the DHS
test results, many of these poisonous candies are still
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readily available to children in communities. AB 2297 will
ensure that DHS is authorized to act quickly in the
future."
Support if amended
The Hershey Food Corporation has taken a support if amended
position and is requesting with Kraft Corporation and the
Grocery Manufacturers of America the following amendments:
1.Limit the applicability of the bill to imported products
containing chili powder and/or tamarind fruit, and
importantly, the accompanying packaging. Hershey states
that reports have consistently cited products with these
ingredients as contributing most significantly to the
problem of lead-adulterated confectionery. Hershey
argues that limiting the focus to these products will
maximize the focus and the resource of DHS and the
community partnerships created by the bill. However,
these are the known sources of lead in candy products. It
may be beneficial to the state to maintain a broader
statute in order to capture the unknown sources.
2.Adhere to the Food and Drug Administration's (FDA)
content guidelines for lead. The proponents of these
amendments state that "a zero lead tolerance standard is
unattainable as lead is ubiquitous to the environment,
with trace amounts in most consumer products, including
food. Lowest detectable limit is similarly unattainable
given the sophisticated and sensitive testing available.
Accordingly, adoption of this standard would render all
imported confectionery adulterated in California. There
are very real international trade implications associated
with restricting/eliminating the sale of all imported
confectionery in the state." They argue that this
standard, which is currently under consideration for
revision, is based on science and has been recognized by
the international community. Some experts believe that
the FDA's current standard is too high, and state that
the FDA is considering lowering it. Given California's
international borders, the state might benefit from
setting its own standard.
3.Require all manufacturers of imported candy containing
chili powder and/or tamarind fruit to annually test and
certify (using endorsed testing procedures) that each
individual product intended for sale in the state is in
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compliance with FDA guidelines for lead and CONEG (the
Council of Northeast Governors) Model Toxics in Packaging
standards for the accompanying packaging. . The CONEG
model legislation was originally drafted in an effort to
reduce the amount of heavy metals in packaging and
packaging components that are sold or distributed
throughout the United States. California has recently
enacted AB 455, while aimed at reducing the amount of
heavy metals in packaging in order to prevent them from
getting into the solid waste stream, may also capture the
purpose stated here. Also, according to the Register's
investigation, the candy being sold in California with
the highest lead levels has come into the country
illegally. Therefore, those candies that are likely to
be at issue are not likely to be captured by these
provisions. Moreover, there may be significant sources
of lead other than chili or tamarind.
4.Authorize DHS, in partnership with County Departments of
Health, to remove from the retail stream any product not
certified.
5.Require DHS to periodically test certified products to
ensure compliance with FDA standards for lead and CONEG
Model Toxics in Packaging standards for packaging, and
require the removal of any products that do not comply.
6.Require DHS develop a listing of all products that have
been certified and partner with County Health Departments
and community-based organizations in disseminating this
information to the public.
Rather than creating a certification process and a program
within DHS to enforce certification it may be prudent to
give DHS the authority to recall or remove products from
California establishments upon making a finding that the
product may cause harm and does not meet state standards
for acceptable levels of lead.
Hershey Foods states, "We believe that these amendments
will enable the Department, in partnership with County
Departments of Health and community groups outlined in the
bill, to immediately identify non-compliant products,
quickly remove them from the retail stream, and focus
additional resources on community awareness and education."
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The author has not yet indicated a willingness to accept
any of these amendments.
Arguments in opposition
Opponents state that since lead occurs naturally in the
environment and because ingredients used in producing candy
may contain lead at levels allowed by FDA, it is nearly
impossible for candy or any other food product to achieve a
zero or lowest detectable level of lead content. The
opponents state that "while we certainly share the goal of
protecting our children from exposure to dangerous levels
of lead in imported candy, we believe the bill as currently
written would not be the most effective approach to
accomplishing this goal. First, the natural occurrence of
lead in the environment prevents most food products
including confectionery from meeting the zero tolerance
level required in AB 2297." Opposition also argues that
the administrative breadth of the bill would limit its
effectiveness and prevents quick enforcement, stating that
any candy product imported into California would be tested
- that is over 20,000 types of products.
Opponents believe that rather than initiating an
exceedingly broad independent state program for lead in
candy, it would be far more effective for California to
coordinate its efforts with those of the FDA, whose
expanded powers would provide far more resources to address
the problem than California could create at the state
level.
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The California Paint Council (CPC) is opposed to the bill
stating, "CPC has no position on the proposal for the
Department of Health to regulate the lead content in
imported candy, but the paint and petroleum industries
should not be required to pay for that new program."
COMMENT
In conversations with representatives from various U.S.
candy manufacturing companies, it was stated that in many
candies, from chocolate to "Jolly Ranchers," it would be
impossible to meet a zero level of lead. Most candies as
well as other foods have at least a small amount of lead
from naturally-occurring uptake in cocoa, sugar beet or
other plants. It was asserted that a zero level would
prohibit many foods from being sold in California. The
Committee and author may wish to consider amending the bill
to set a standard to be the lowest level between the FDA
and .2 parts per million, at any given time.
PRIOR ACTIONS
Assembly Floor: 74 - 2 Pass
Assembly Appropriations: 16 - 3 Do Pass as Amended
Assembly Health: 11 - 3 Do Pass
POSITIONS
Support: Environmental Health Coalition (sponsor)
City of Chula Vista
Consumer Attorneys of California
Los Angeles Unified School District
Planning and Conservation League
Sierra Club California
Oppose: California Paint Council
California Manufacturers and Technology
Association
Grocery Manufacturers of America
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